Trial Outcomes & Findings for A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood (NCT NCT05965583)
NCT ID: NCT05965583
Last Updated: 2026-05-12
Results Overview
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
COMPLETED
PHASE1
14 participants
Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.
2026-05-12
Participant Flow
This study was an open-label, single-center, two-period, fixed-sequence trial in healthy male subjects. Each subject participated in two treatment periods (Days -3 to 4 in Period 1 and Days -3 to 7 in Period 2) and received the Reference treatment (R) in Period 1 and the Test treatment (T) in Period 2.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 1815368 (R), Then Itraconazole and BI 1815368 (T)
Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R.
On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h).
This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days.
|
|---|---|
|
Period 1 (Reference Treatment R)
STARTED
|
14
|
|
Period 1 (Reference Treatment R)
COMPLETED
|
14
|
|
Period 1 (Reference Treatment R)
NOT COMPLETED
|
0
|
|
Washout Period
STARTED
|
14
|
|
Washout Period
COMPLETED
|
14
|
|
Washout Period
NOT COMPLETED
|
0
|
|
Period 2 (Test Treatment T)
STARTED
|
14
|
|
Period 2 (Test Treatment T)
COMPLETED
|
13
|
|
Period 2 (Test Treatment T)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
BI 1815368 (R), Then Itraconazole and BI 1815368 (T)
Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R.
On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h).
This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days.
|
|---|---|
|
Period 2 (Test Treatment T)
Adverse Event
|
1
|
Baseline Characteristics
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood
Baseline characteristics by cohort
| Measure |
BI 1815368 (R), Then Itraconazole and BI 1815368 (T)
n=14 Participants
Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R.
On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h).
This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days.
|
|---|---|
|
Age, Continuous
|
39.6 Years
STANDARD_DEVIATION 9.3 • n=1512 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1512 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of a PK endpoint or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value for one period to the statistical assessment. Only subjects with available PK data were included in this analysis.
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Outcome measures
| Measure |
BI 1815368 (R) Alone
n=14 Participants
Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R.
|
Itraconazole and BI 1815368 (T)
n=13 Participants
On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole (9 doses in total) with 240 ml of water after an overnight fast of at least 9 hours.
On Day 1/Visit 2 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1815368 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
3876.73 nanomoles*hour/Liter (nmol*h/L)
Standard Error NA
Adjusted geometric standard error = 1.05
|
8178.83 nanomoles*hour/Liter (nmol*h/L)
Standard Error NA
Adjusted geometric standard error = 1.06
|
PRIMARY outcome
Timeframe: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of a PK endpoint or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value for one period to the statistical assessment. Only subjects with available PK data were included in this analysis.
Maximum measured concentration (Cmax) of BI 1815368 in plasma is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint.
Outcome measures
| Measure |
BI 1815368 (R) Alone
n=14 Participants
Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R.
|
Itraconazole and BI 1815368 (T)
n=13 Participants
On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole (9 doses in total) with 240 ml of water after an overnight fast of at least 9 hours.
On Day 1/Visit 2 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1815368 in Plasma (Cmax)
|
704.47 nanomoles/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.08
|
847.84 nanomoles/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.08
|
SECONDARY outcome
Timeframe: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of a PK endpoint or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value for one period to the statistical assessment. Only subjects with available PK data were included in this analysis.
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint.
Outcome measures
| Measure |
BI 1815368 (R) Alone
n=14 Participants
Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R.
|
Itraconazole and BI 1815368 (T)
n=13 Participants
On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole (9 doses in total) with 240 ml of water after an overnight fast of at least 9 hours.
On Day 1/Visit 2 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1815368 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
3850.70 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.05
|
8133.88 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.06
|
Adverse Events
BI 1815368 (R) Alone
Itraconazole Alone
Itraconazole and BI 1815368 (T)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1815368 (R) Alone
n=14 participants at risk
Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R.
|
Itraconazole Alone
n=14 participants at risk
On Day -3 to Day -1/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole (3 doses in total), once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
Itraconazole and BI 1815368 (T)
n=13 participants at risk
On Days 1 to 6 /Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole (6 doses in total) with 240 ml of water after an overnight fast of at least 9 hours. On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
14.3%
2/14 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
General disorders
Fatigue
|
7.1%
1/14 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
23.1%
3/13 • BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place